Highlights from the August 25, 2021 Listening Session on Health Care Standards Development, Adoption, and Implementation

Subcommittee on Standards 1

Predictability Roadmap – Foundation ofListening Session (2018-2019) Focus on immediate and longer-term needs identified

by industry and within the Subcommittee’s charter: • Build on prior “Predictability Roadmap” recommendations

• Improve availability and/or access to updated versions ofstandards

• Address clinical, administrative and other data intersections

• Support move to interoperability

• Improve regulatory processes to enable access to updated ornew standards

• Improve standards update and adoption processes Industry message to NCVHS and HHS • Reduce administrative burdens

Subcommittee Project: Standardization of Information for Burden Reduction and Post-Pandemic America

Intent: Build on Predictability Roadmap and identify current industry innovativeactivities, priorities and burden

Phase 1: Assess the current health data standards landscape

Listening Session and Request for Written Comments (August 2021)

o Analyze the listening session information; identify issues and opportunities.

o Conceptualize potential solutions to improve efficiency and reduce burden

o Develop workplan for Phase II

Phase II: Develop and refine recommendations based on assessment of standards input,industry consultation and NCVHS input

o Standards: Development, regulation, implementation, enforcement

o Convergence: Coordinate efforts with ONC and HITAC

o Identify other opportunities related to HHS priorities 3

Standardization of Information for Burden Reduction and Post-Pandemic America (cont.)

Additional topics that may be considered for evaluation: • FHIR and APIs – support interoperability in health care • All-Payer Claims Databases (APCD) Common Data Layout (CDL)

Consistency of reporting and/or exchange of social risk data • Conformance/Enforcement improvement opportunities • Sanctioned exceptions and alternatives to HIPAA transaction standards • Health data flows beyond traditional HIPAA and HITECH trading partners

• Social and structural determinants of health; patient social services programs • Public health, infectious diseases and vital statistics • Pandemic-related lessons learned • Patient/consumer-driven data

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Today’s Focus

• Preliminary, draft themes from responses to Request forComments (RFC)

• Highlights from Panel Sessions Panel 1: Lessons learned from national standards coordination (beyond healthcare) Panel 2: Updates from standards organizations and industry Panel 3: Semantic Harmonization Panel 4: Public Health and Social Risk Data updates

• Next Steps 5

Request for Comments 1. How can data sharing be improved between patients,Request for Comments released in providers, payers, public health system, and other actors in

June 2021 with 4 questions. health care? What are the barriers to these improvements?

• 30+ letters received to date 2. Are there any new standards or use cases available or under development that should be considered by NCVHS for• Several with multiple signatory recommendation to HHS for adoption to support

organizations interoperability, burden reduction and administrativesimplification?

3. How have other industries effectively implemented, tested, and certified standards for data and their exchange that couldbe considered for health care?

4. What short term, mid-term and long-term opportunities or solutions do you believe should be priorities for HHS in thenext 5 to 10 years?

To view all public comments visit: https://ncvhs.hhs.gov/wp-content/uploads/2021/08/Public-Comments-Standards-Subcommittee-Meeting-August-16-2021.pdf

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Themes from Responses to Request for Comments - Preliminary • Focus on the patient at the center • Support the provider work flow • Code sets/value of code sets; • Testing and Return on Investment for

standards • Privacy and Security • Interoperability through FHIR • Public Health and Vital Records • Social Risk Data • Payer Portals

• Mobile Apps and Patient Education • Patient Matching/Patient ID • Standards Development process by SDOs • Standards Adoption Process by Government • Access to APCD Data • Operating Rules when applicable • Enforcement of correct use of data standards

or transactions • EFT Fees • Adoption of certain standards e.g.

attachments, acknowledgements, differentdental standard, different pharmacy standard

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Preliminary Highlights from Panel Discussions

from the Moderators

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Panel 1: National Standards Coordination (Functions and Processes) • Manage cross-sector, multi-stakeholder coordination and

collaboration on standards development/maintenance. • Standards work requires dedicated resources • Identify and communicate sector-wide standards issues

which create barriers to development or use • Create roadmaps for solving issues in standardization

and conformity assessment, and maintain ongoing reporting on measures of success

• Assessing standards conformance and compliance isimportant and measures should be established

• Regulatory processes for standards adoption and implementation that successfully manage transitions ofstandards and technologies may require a legislatedframework that does not adopt specific standards inregulations or by reference, but allows a more flexibleapproach such as agency recognition of standards

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Panel 2: Information Exchange and HIPAA –Today and Beyond • Greater coordination/collaboration needed

between SDO’s • Some coordination taking place for mapping data

elements between HL7 and X12; between HL7and NCPDP

• Measure benefits, outcomes, opportunities; • Gaps in current X12 standards – Work arounds

and future opportunities; • Update rules or write new regulations to

address gaps for prior authorization, Real TimePharmacy Benefit Check, Advanced EOB (tosupport No Surprises Act);

• Test standards before adoption; • HHS should publicize requirements for ROI

data needs; • HHS should support pilots for standards, e.g.

HIPAA; current HL7 FHIR Exception for PA;

• HHS should adopt standard(s) forattachments, acknowledgements, NCPDP Script for ePA for pharmacy consistent withPart D under HIPAA

• Lack of transparency and/or action on status ofNCVHS recommendations, e.g. attachments;acknowledgements, NCPDP Script, F6. (letter and oral input from Cooperative Exchange).

• Extend HIPAA to other entities, e.g. practicemanagement systems and other vendors,similar to the extension seen in HITECH to raise standard compliance accountability.

• Two versions or models of standards could co-exist in use at the same time because systemchanges take time (5010/8010 or X12 andHL7);

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Panel 3: Semantic Harmonization (1)

• Representatives from Kaiser Permanente, Office of the National Coordinator for Health IT, National Library of Medicine, HL7, American Medical Association,SNOMED International weighed in

• Functional interoperability is still lacking but we are closing in on data models

• Consensus is that current exchange standards may be sufficient for semanticinteroperability • No efforts to formally model semantics (ontologies) for harmonization (just use the

same coding systems)

• No need for new terminologies – SNOMED, ICD10-CM, CPT, LOINC, etc. (use NLP forthe rest?)

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Panel 3: Semantic Harmonization (2)

• Unanimous consensus that current efforts are working andsufficient: Manually curated terminologies

Exchange with automated mappings where available, exact text matching where not

Cross-walks

• No one asked NCVHS to do anything other than support the status quo • No opinion that deeper modeling is needed, just brute force

methods (manual curation, cross-walks, text processing) 12

Panel 4: Public Health and Social Risk Data

• Consider both social and structural determinants of Social Risk Data – to address social risk versus social need • Collection and use of social service data will require inter-agency and cross-sector

coordination to achieve more uniform collection and appropriate access and use of social risk data. • Data sources for administrative and vital records data originate in provider/payer

systems, making industry key partners • Standards along with a national coordinated system that includes workforce training,

enforcement, validation, and imputation for use of the standards is needed • Sustainable funding for modernization and revised reimbursement arrangements for

public health data access should be a priority for federal, state and local governments • Variation in collection and access laws vary across states. Federal actions to update

outdated laws may reduce variations 13

Contextual Info

1. NCVHS Charter/Subcommittee Charge 2. Predictability Roadmap 3. HITAC Suggestions 4. Project scope document: available here or from

this link: https://ncvhs.hhs.gov/wp-content/uploads/2021/07/NCVHS-SS-project-scoping-convergence-2021-06-21-508.pdf

5. Recording of Panel Discussions: https://ncvhs.hhs.gov/transcripts-minutes/recording-standards-subcommittee-listening-session-august-25-2021/

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Next Steps for Subcommittee onStandards

Develop a timeline to: 1. Finalize analysis of input from letters and

listening session2. Complete identification of themes from letters to

RFC and listening session and how they inform the Subcommittee’s project

3. Associate themes to relevant Federal and/or State parties that could be interested

4. Refine workplan and identify recommendations5. Review findings with CMS, ONC/HITAC

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Standards Subcommittee Charge Monitors and makes recommendations to the full NCVHS:

• Identify issues and opportunities in health data standards; • Provide outreach, liaison, and consultation with, and serve as a public forum on health

information technology standards for the health care industry and federal, state and localgovernments; • Make recommendations related to electronic standards and operating rules under HIPAA,

privacy and security standards, health terminologies and vocabularies; • Make recommendations on strategies to promote a continuing process of developing,

coordinating, adopting, implementing and maintaining standards. These strategies may include public information and educational efforts as well as research and development efforts; • Participate in development/publication of the Report to Congress on HIPAA

Administrative Simplification • Collaborate with other Federal Advisory Committees on cross-cutting issues as

appropriate and when delegated by the Full Committee 16

Discussion

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